Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398340
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-23
Brief Title:
Identifying Wearable Biomarkers to Monitor Dietary Intake
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Identifying Physiological Biomarkers for Monitoring Dietary Behaviours
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FoodSense
Brief Summary:
Background Measuring what people eat is a challenge in nutrition research Traditional methods like food diaries rely on self-reporting of individuals and suffer from poor accuracy and recall bias
Aims This project aims to identify physiological biomarkers related to food and energy intake which may be used to develop an objective tool to estimate individuals food intake in future Eating behaviours are accompanied by significant physiological changes such as skin temperature blood oxygen saturation pulse rate etc The investigators intend to investigate whether monitoring these physiological changes can help us estimate eating behaviour such as meal size eating speed and duration of meals
Study design Ten healthy adults will be invited for two study visits at NIHR Imperial Clinical Research Facility Each visit will last for approximately 2 hr They will consume a high- and low-calorie meal designed by nutritional researchers in a randomised order During eating events the investigators will track their physiological changes via a bedside monitor and wearable sensors Blood samples will be taken from participants to measure their glycaemic response Associations between energy load glycaemic response and physiological changes will be investigated Our findings may promote an accelerated development of a wearable tool for dietary assessment in future
Aims This project aims to identify physiological biomarkers related to food and energy intake which may be used to develop an objective tool to estimate individuals food intake in future Eating behaviours are accompanied by significant physiological changes such as skin temperature blood oxygen saturation pulse rate etc The investigators intend to investigate whether monitoring these physiological changes can help us estimate eating behaviour such as meal size eating speed and duration of meals
Study design Ten healthy adults will be invited for two study visits at NIHR Imperial Clinical Research Facility Each visit will last for approximately 2 hr They will consume a high- and low-calorie meal designed by nutritional researchers in a randomised order During eating events the investigators will track their physiological changes via a bedside monitor and wearable sensors Blood samples will be taken from participants to measure their glycaemic response Associations between energy load glycaemic response and physiological changes will be investigated Our findings may promote an accelerated development of a wearable tool for dietary assessment in future
Detailed Description:
1 Participants
10 healthy male and female participants This is a pilot study in a new area and therefore a formal power calculation is not possible
2 Recruitment
Participants will be recruited from existing healthy volunteer databases and by advertisement in public places Adverts may be placed in newspapers and put up in public buildings A contact number on the advert will enable potential participants to contact the research team at Imperial College London Participation in the study will be entirely voluntary No undue influence will be exerted by the researchers Participants will be free to withdraw from the study at any time
3 Pre-Screening Questionnaire
A pre-screening questionnaire considering the inclusion and exclusion criteria will be completed to establish eligibility For subjects who complete the questionnaire but do not continue to participate their data will not be saved
4 Informed Consent
All participants will sign informed consent before starting the study at the beginning of the 1st main study visit
5 Main Study Visits
Ten healthy subjects will attend two study visits at National Institute for Health and Care Research NIHR Imperial College London Clinical Research Facility post code W12 0NN London UK The participants will consume a high- and low-calorie meal designed by nutritional researchers in a randomised order Randomization will be performed using the sealed envelope website by an independent researcher ie not linked to the study During eating events physiological changes such as skin temperature blood oxygen saturation pulse rate etc and eating movements will be measured via a bedside monitor and non-invasive wearable sensors Blood samples will be taken at pre-determined time-points starting 5 minutes before the meal and lasting for 60 minutes postprandially at -5 15 30 45 60 min A total of 25 ml blood will be taken per visit
10 healthy male and female participants This is a pilot study in a new area and therefore a formal power calculation is not possible
2 Recruitment
Participants will be recruited from existing healthy volunteer databases and by advertisement in public places Adverts may be placed in newspapers and put up in public buildings A contact number on the advert will enable potential participants to contact the research team at Imperial College London Participation in the study will be entirely voluntary No undue influence will be exerted by the researchers Participants will be free to withdraw from the study at any time
3 Pre-Screening Questionnaire
A pre-screening questionnaire considering the inclusion and exclusion criteria will be completed to establish eligibility For subjects who complete the questionnaire but do not continue to participate their data will not be saved
4 Informed Consent
All participants will sign informed consent before starting the study at the beginning of the 1st main study visit
5 Main Study Visits
Ten healthy subjects will attend two study visits at National Institute for Health and Care Research NIHR Imperial College London Clinical Research Facility post code W12 0NN London UK The participants will consume a high- and low-calorie meal designed by nutritional researchers in a randomised order Randomization will be performed using the sealed envelope website by an independent researcher ie not linked to the study During eating events physiological changes such as skin temperature blood oxygen saturation pulse rate etc and eating movements will be measured via a bedside monitor and non-invasive wearable sensors Blood samples will be taken at pre-determined time-points starting 5 minutes before the meal and lasting for 60 minutes postprandially at -5 15 30 45 60 min A total of 25 ml blood will be taken per visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None